This invention relates to appliances for use with stomas.
An ileostomy is a surgical procedure in which the small intestines are surgically rerouted to the outside of the body. People require an ileostomy when the large intestines or rectum are affected by injury or disease to the point where they can no longer function and must be removed. Conditions which require removal of the large intestine or rectum include ulcerative colitis, polyposis, and tumors. When a surgeon removes the large intestine or rectum from a patient, the surgeon must also make a new passageway for removal of waste from the body. The surgeon does this by connecting the end of the small intestine (or a portion of the large intestine) to the outside of the body, and creating an opening in the skin. The opening in the skin is call a stoma, and is usually located on the right side of the abdomen near the waist. Related surgical procedures include the colostomy, in which colon is surgically rerouted to a stoma on the body, and the urostomy, in which the urinary tract is rerouted to a stoma on the body. Each of these ostomy procedures requires similar post-operative hygiene and appliances.
After ileostomy surgery, patients are relieved from the painful conditions requiring the ileostomy. However, the patients must use special appliances and use special care to remove waste material from the body through the ileostomy and stoma. Patients must wear a pouch over the stoma to collect waste material. The pouch is connected to the stoma with a fluid connector and a barrier seal around the stoma. The barrier seal may be is glued to the body around the stoma with special adhesive. The barrier seal is absorbent so that it absorbs any leakage that might occur through the fluid connector. The appliance may be disposable, in which case the pouch, fluid connector, and barrier seal are replaced as necessary. The appliance may be reusable, in which case the pouch must be emptied often, the fluid connector must be cleaned and reinstalled, and the barrier seal must be cleaned or replaced. The barrier seal must be replaced every two to three days. With proper vigilance to the hygiene requirements of the appliances, irritation of the stoma and skin around the stoma can be limited and odor associated with leakage can be avoided. With these special appliances, patients can engage in a very normal lifestyle, except for the time necessary to maintain the appliances and care for the stoma and experience of discomfort attendant to typical shortcomings of available appliances. The hygienic regimen is, however, burdensome and imperfect in avoiding irritation. Any device or method that lessens the burden on the patient and reduces the irritation of the stoma and surrounding skin will be useful for all ileostomy patients.
The stoma is a generally circular or annular opening in the abdomen. It is formed by piercing the skin to form a hole, pulling the ileum (the end of the small intestine) through the hole in the skin, and everting a short segment of the small intestine (turn it inside out), and suturing the everted segment to the skin. The sutures create a circle of stitches around the stoma. The stoma protrudes slightly from the surface of the skin, and the suture circle is slightly elevated.
The typical ileostomy pouch has a stoma opening which is aligned with the stoma, so that effluent flows from the small intestine through the stoma and stoma opening into the pouch. The pouch is held on the body, and stoma opening held in place over the stoma, with a faceplate that is taped to the body. The faceplate has a stoma opening which is ringed by a flanged fluid connector which connects to the stoma opening of the pouch. The stoma opening is the same size or slightly larger than the stoma, and may include a flexible silicone gasket with an opening the same size as the stoma. The faceplate is taped to the body with an adhesive disk call a barrier seal. The barrier seal is adhesive on both sides, and tapes the faceplate to the body. (The faceplate may also be glued to the body. Many patients also apply microporous tape around the faceplate before attaching the pouch to the faceplate, and some manufacturers supply the faceplate with a picture frame of tape.) The barrier seal is also absorbent, so that it absorbs any effluent that leaks from the stoma connection to the pouch. The pouch is fitted over the flange of the faceplate, and locked in place with a snap fit closure (like an aspirin bottle cap). This system is sometimes referred to as a two piece system, and may be described in various ways. For example, ConvaTec refers to the faceplate/barrier seal assembly as a skin barrier with a flange. The barrier seal is sometimes referred to as a skin seal, barrier ring seal, or wafer or disc.
In contrast to the two-piece system, a one piece system integrates the before mentioned components into one disposable unit who""s overall function is similar to the two piece system. In another type of pouch, the stoma opening on the pouch has a tacky silicone ring which fits directly around the stoma, and the adhesive barrier seal connects the pouch directly to the skin around the stoma. Non-adhesive pouches use a similar setup, with an O-ring seal fitting around the stoma and the stoma opening of the pouch fitting directly over the O-ring, and the entire assembly is held on the body with a belt.
The integrity of the entire appliance depends on the effectiveness of the skin barrier seal. The barrier seal is intended to absorb effluent and keep it from contacting the skin around the stoma (referred to as the peristomal skin). When it fails in protecting the skin, the peristomal skin becomes irritated or infected. The skin barrier will not adhere to irritated or infected skin, and will not work to protect the skin. Thus any outbreak of peristomal skin irritation or infection can be very difficult to cure.
The inventions described below include several improvements for ostomy appliances. The faceplate/barrier seal assembly includes a dispersive blotter ring installed between the faceplate and the barrier seal to distribute leaked effluent more evenly around the stoma opening, thereby prolonging the useful life of a barrier seal. The typical ring seal is improved by the addition of a highly conformal silicone foam ring. The silicone foam exhibits a balance of resilience and conformance beyond that of silicone ring seals, and expands into stoma concavities and irregularities that would otherwise remain as leaks. The silicone foam ring is suspended over the stoma with a suspension membrane which allows the foam ring to move and follow axial and radial displacements of the stoma relative to the faceplate. Addition of a superiorly located compressing and supporting ring assists in urging the silicone foam ring into contact with the stoma at its base. The faceplate assembly provides better protection to peristomal skin and prevents leaks better than currently available faceplate assemblies. A method of making silicone foam without use of bio-incompatible constituents or processing substances is also presented, so that the device may be made without fear of harm to the body due to chronic exposure to chemicals diffusing from the ring seal.